By Carl Reed

OxyContin® tablets are a controlled-release oral formulation of oxycodone hydrochloride, an opioid analgesic. It is indicated for the management of moderate to severe pain in cases where a continuous, around-the-clock analgesic is needed for an extended period of time. Patients with cancer and chronic constant back pain not resolved through surgery are likely to be candidates for OxyContin® therapy.

OxyContin® is not indicated or intended for use as an as-needed (PRN) analgesic1. It also is not indicated in the immediate post-operative period (the first 12 to 24 hours following surgery) or if the pain is mild and/or not expected to last for an extended period of time. It is only indicated post-operatively if it was in use pre-operatively or if the pain is expected to persist for an extended period. The 80 mg and 160 mg tablets are reserved for patients who are tolerant of the effect of opiates and require higher doses of the medication. A new U.S. Food and Drug Administration black box warning has been added to OxyContin® describing the abuse potential.2

Physicians are directed to individualize treatment plans for pain patients, starting at the appropriate level of care based upon pain management guidelines outlined by the World Health Organization, the Agency for Healthcare Research and Quality, or the American Pain

Society. Visit www.ampainsoc.org and www.ahcpr.gov for more information about pain management.

Benefit managers need to be aware that some beneficiaries may be using this drug inappropriately and other beneficiaries may be fraudulently obtaining OxyContin® prescriptions and giving or selling the drug to others. OxyContin® is very popular on the black market. When crushed and inhaled, OxyContin® pills generate a high similar to heroin but more dangerous. The higher OxyContin® dosages, especially the 80 mg and 160 mg tablets, are particularly popular and potent.

As defined earlier, OxyContin® is a sustained release formulation of oxycodone. More frequently prescribed narcotic analgesics (i.e., Percodan®, Percocet®, Roxicet®, Tylox®) typically have 5 mg of immediate release oxycodone in them. OxyContin® 80mg tablets are equivalent to 16 tablets of 5 mg oxycodone and, when crushed, release all of that medication immediately. Individual OxyContin® tablets are sold for illegal use at 10 to 12 times the average wholesale price of the drug. The average wholesale price (AWP) of the different doses of the medication are shown in Table 1.

Management Strategies
In addition to potential abuses, prices and utilization in the narcotic analgesics class are trending upward. In 2001, the average AWP per prescription in the class was $36.96.3 Based on a population of 3 million commercially insured health plan members enrolled in a carved-out prescription drug programs, the 2001 per member per year (PMPY) cost for this class was $15.66, based on 0.42 prescriptions per year, an increase of 24.7% from 2000.4 The 2003 PMPY for this population is projected to be $22.64.5

The clinician-prescriber communication that is the cornerstone of prior authorization (PA) makes PA one of the most effective management strategies for this frequently abused drug. OxyContin® is indicated for acute, chronic pain of long duration. Because it is not indicated for acute pain, post-surgical pain, or PRN dosing, PA is appropriate and warranted.

Plan sponsors also can manage OxyContin® therapy using adjudication system edits for quantity limits and duration of therapy limits. For instance, a plan sponsor might indicate that no more than 2 tablets daily of any strength of the drug will be allowed under the plan design. When properly dosed, OxyContin® is only needed every 12 hours. The plan sponsor also might indicate, in the absence of a terminal illness or a condition of intractable pain that will not resolve, that no more than 90 days of medication be allowed without additional documentation substantiating medical necessity.

Monitoring Utilization
Pharmacy benefit managers typically produce information reports on plan members using multiple pharmacies and multiple providers for drugs in similar therapeutic classes. These reports, which must be carefully produced to be compliant with the Health Insurance Portability and Accountability Act (HIPAA), are helpful in identifying potential abuse of OxyContin® and other controlled substances. Ongoing manage-ment and monitoring of OxyContin® utilization is most effective when medical diagnoses are available.

The subjectivity of effective pain management care often makes health plans, insurance companies, and pharmacy benefit managers (PBMs) reluctant to initiate utilization controls in pain management. If a plan sponsor suspects OxyContin® abuse is occurring, institution of prior authorization is a first step in correcting the problem. If patient-specific problems are suspected, plan sponsors should evaluate medical necessity and appropriateness. Insurance carriers can help plan sponsors if the drug benefit is not carved out. Plan sponsors with drug benefit carve-outs should work with their PBMs to manage the issue.

Pain Management
While monitoring for abuse is an important aspect of managing OxyContin® usage, it is imperative to remember that this drug is an important tool in a physician's arsenal for pain management. Pain is under treated because of the stigma attached to taking "narcotics", fear of addiction, and fear on the part of providers of increased scrutiny from regulatory agencies. Programs devised should not diminish the ability of patients with legitimate needs from getting appropriate pain management therapy, be it with OxyContin® or any other pain medication.

1,2 OxyContin® Package Insert, p. 1-26: ©2001 Purdue Pharma L.P.
3 2001 Drug Trend Report, p. 71; ©2002, Express Scripts, Inc.
4,5 2001 Drug Trend Report, p. 26-27; ©2002, Express Scripts, Inc.

Reed is Director of Pharmacy for Preferred Care, a New York HMO with more than 200,000 lives. He is also a member of the New York State Medicaid Pharmacy & Therapeutics Committee.

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